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Clinical Trials/NCT05153928
NCT05153928
Unknown
Not Applicable

Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment

Ahmed Ali Mahmoud2 sites in 1 country100 target enrollmentApril 10, 2021

Overview

Phase
Not Applicable
Intervention
Norethisterone acetate
Conditions
Abnormal Uterine Bleeding
Sponsor
Ahmed Ali Mahmoud
Enrollment
100
Locations
2
Primary Endpoint
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
Last Updated
4 years ago

Overview

Brief Summary

  1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
  2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Detailed Description

The aim of the present study is: 1. to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination 2. to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma

Registry
clinicaltrials.gov
Start Date
April 10, 2021
End Date
December 25, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Ahmed Ali Mahmoud
Responsible Party
Sponsor Investigator
Principal Investigator

Ahmed Ali Mahmoud

Dr

Assiut University

Eligibility Criteria

Inclusion Criteria

  • (1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.
  • (3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;

Exclusion Criteria

  • (1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.

Arms & Interventions

fibroid cases

Norethisterone acetate for 5 months

Intervention: Norethisterone acetate

adenomyosis

Norethisterone acetate for 5 months

Intervention: Norethisterone acetate

Outcomes

Primary Outcomes

is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis

Time Frame: 6 months

Symptomatic improvement

Study Sites (2)

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